This is a randomized, multicenter phase 2 clinical trial to evaluate the efficacy and safety of capecitabine plus pyrotinib versus capecitabine plus trastuzumab plus pertuzumab in patients who have HER2 positive metastatic breast cancer and have not received systemic anticancer therapy for advanced disease.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
200
Pyrotinib 400mg orally daily until progressive disease
as instruction
Progression Free Survival
Time frame: Approximately 42 months
Adverse Events and Serious Adverse Events
AEs+SAEs
Time frame: From the first drug administration to within 28 days for the last treatment
Overall Survival
Time frame: Up to 2 years
Objective Response Rate
Time frame: Approximately 42 months
Duration of Objective Response
Time frame: Approximately 42 months
Clinical Benefit rate
Time frame: From the start of randomization to 6 months
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